🍔 Food 💊 Drugs 🏥 Medical Devices
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13 Class III

Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

AVKARE LLC 20230613 Ongoing
Distributed: Nationwide in the USA.
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SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. Class I

Reason: Chemical Contamination: FDA testing found Presence of methanol

Jarman's Midwest Cleaning Systems, Inc. 20230327 Terminated
Distributed: Nationwide in the USA
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Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. Class I

Reason: Chemical Contamination: FDA testing found Presence of methanol

Jarman's Midwest Cleaning Systems, Inc. 20230327 Terminated
Distributed: Nationwide in the USA
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Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01 Class II

Reason: CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.

Jarman's Midwest Cleaning Systems, Inc. 20230327 Terminated
Distributed: Nationwide in the USA
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Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30 Class III

Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Amring Pharmaceuticals Inc 20230612 Terminated
Distributed: Nationwide in the USA.
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GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3 Class III

Reason: Labeling: Label Mix-up

HF Acquisition Co LLC 20230606 Terminated
Distributed: Distributed in TX, AZ and CA only
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Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83. Class II

Reason: CGMP Deviations

SUN PHARMACEUTICAL INDUSTRIES INC 20230503 Terminated
Distributed: Product was distributed to 19 distributors nationwide.
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Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle). Class II

Reason: Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.

Golden State Medical Supply Inc. 20230525 Terminated
Distributed: Nationwide in the USA
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Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05 Class II

Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Viatris Inc 20230525 Terminated
Distributed: Product was distributed to 10 distributors who may have further distribute the product to the retail level.
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ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1 Class II

Reason: Mislabeling: preservative free product labeled as preserved.

Empower Clinic Services LLC dba Empower Pharmacy 20230512 Completed
Distributed: Distributed Nationwide in the USA
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